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OpenTrials
Completed

NCT Number: NCT02930863

Pulse Oximetry With Automated Verbal Prompts

This study will evaluate the effectiveness of an automated voice prompting system on post operative hypoxia within the Postoperative Anesthesia Care Unit (PACU). This will be done to detect an improvement of the patient experience and provider care through a decrease in the number of peripheral capillary oxygen saturation (SpO2) monitor alarms via the patients own ability to follow the instruction and improve their SpO2 levels.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health

Gainesville, Florida, 32610, United States

About this study

The investigators will examine and observe the patient's stay in the PACU and utilize the pulse oximetry software and data to analyze the ability to evaluate the difference in patient oxygenation levels and supplemental oxygen use with automated verbal prompted monitoring versus a standard care control group. As well as determine if automated verbal prompted monitoring leads to less monitor alarms and subsequent improvement of subjective alarm fatigue and patient satisfaction with their care versus standard care.

The pulse oximeter will have a finger probe that will be attached to the patient's middle finger to read the patient's SpO2 levels. Each time the participant's pulse oximetry value declines to 93% or less, an automated verbal prompt, created via the software, will generate as a soft prompt. This will be followed up by a hard prompt if no improvement is seen in their oxygenation level after a period of time. A positive feedback elicitation will be given if the participant's saturation levels increase above 93%. This automated verbal prompt guidance will take place during the entirety of the investigational group's PACU stay.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • planned general anesthetic
  • ability to provide informed consent

Exclusion criteria

  • use of regional anesthesia
  • altered mental status
  • hearing impairment requiring assistive devices
  • inability to hear normal conversational voice during the consent process
  • inability preoperatively to squeeze probe finger against thumb for any reason
  • baseline SpO2 less than or equal to 93% (on room air or baseline home oxygen requirement)
  • history of methemoglobinemia
  • suspected or confirmed carbon monoxide (CO) poisoning
  • planned admission to an intensive care unit

Treatment and study plan

pulse oximetry software

Other

This pulse oximetry software will utilize automated verbal prompts that direct the patients to breathe when their pulse oximetry reading falls at or below 93%.

Brief post-PACU stay survey.

Behavioral

Complete a brief post-PACU stay survey focused around their satisfaction and experience during their time in the PACU.

Primary outcomes

  1. Change in the frequency of a participant's SpO2 level falling below 87%

    Time frame: Change from baseline up to 24 hours

    SpO2 will be monitored using the standard pulse oximeter system

Secondary outcomes

  1. Change between the study groups number of pulse oximetry alarms

    Time frame: Change from baseline up to 24 hours

    SpO2 will be monitored using the standard physiologic monitoring system

  2. Change between the study groups level of alarm fatigue

    Time frame: Change from baseline up to 24 hours

    Number of participants reporting a decreased level of alarm noise

  3. Change between the study groups level of postoperative care satisfaction

    Time frame: Change from baseline up to 24 hours

    Number of participants reporting alarm noise affected their level of postoperative care satisfaction

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Prevention of Post Operative Hypoxia in the Post Anesthesia Care Unit Using Pulse Oximetry With Automated Verbal Prompts

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Oct 12, 2016
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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